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Tabletop Steam Sterilizer Installation & Users’ Manual A50B Revision01 Release date: 2018/03/01

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Page 1: Tabletop Steam Sterilizer - Zone Medical€¦ · Tabletop Steam Sterilizer Installation & Users’ Manual A50B Revision:01 Release date: 2018/03/01 . I Preface Thank you for purchasing

Tabletop Steam Sterilizer

Installation & Users’ Manual

A50B

Revision:01 Release date: 2018/03/01

Page 2: Tabletop Steam Sterilizer - Zone Medical€¦ · Tabletop Steam Sterilizer Installation & Users’ Manual A50B Revision:01 Release date: 2018/03/01 . I Preface Thank you for purchasing

I

Preface

Thank you for purchasing this HäTmed table-top steam sterilizer. This User Manual describes usage guidelines

for the autoclaves A50B, A60B and A70B (referred to as “autoclave” throughout the manual). These guidelines cover

installation, initial commissioning, standard operation, safety precautions and maintenance requirements. For your

safety and sterilization quality, please read this User Manual carefully before you start operation of the autoclave.

Intended Use HäTmed A50B, A60B and A70B are suitable for use in medical facilities, such as general medical institutions or

dental clinics. HäTmed sterilizers are designed and manufactured in strict compliance with EN 13060-2014. A50B,

A60B and A70B are B-class autoclaves that are designed for high standard sterilization of hollow instruments, packed

instruments, geared instruments and textiles.

Do not sterilize any liquids with this autoclave. Failure to follow

this instruction may lead to damage of the instruments and this

autoclave.

Symbols Symbols and their meaning in this Manual:

Symbol Indication Explanation

Risk to Health

Indicates a dangerous situation, such as high

voltage or current, if not avoided, could cause

life-threatening injuries.

Danger of Burns

Indicates danger of burns, such as hot steam or

surfaces.

Critical Instructions

Indicates a critical instruction which, if not

strictly followed, may lead to damage to the

instruments or this autoclave.

Important Information Indicates important information.

Protective earthing Indicates protective earthing conductors.

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II

Symbols on the device:

Symbol Description

Danger of Burns

Manufacturer of this medical device

Date of manufacture of the medical device

Serial number of the medical device by the manufacturer

EU Representative of the manufacturer of the medical device

This User Manual contains important safety information. Failure to comply

with the safety instructions could cause human injuries or material damage.

Please read this User Manual carefully before using the device. The manual

contains important safety information. The performance and life-span of this

autoclave depends on the care accorded to it. Please store this User Manual

carefully and in close proximity to the autoclave. It is a component of the

product.

In affixing this CE mark, the manufacturer declares that this medical device

fulfills the requirements of the medical device directive. The 4-digit number

confirms that this is monitored by an approved certification body.

This symbol reminds the users to refer to the User Manual for important

information.

Safety Instructions:

Only use this device for its intended use as described in this User Manual. While operating this

autoclave, please make sure the safety instructions given below and in the individual chapters

of this User Manual are strictly followed.

No Liquid Do not sterilize any liquids with this autoclave.

Qualified

Personnel

The sterilization of instruments and textiles using this autoclave may

only be carried out by trained personnel.

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III

Power cable

and

power plug

Never change the main cable or power plug. Never use a damaged

power cable or plug.

Never operate the device if the plug or power cable is damaged. The

power cable and plug should only be replaced by authorized personnel.

Never unplug by pulling on the power cable. Always take hold of the

power plug itself.

Ensure that the power cable is not jammed or knotted.

Never place the cable close to a source of heat.

Never fix the power cable with sharp objects.

Setting up

and

installation

Only have the autoclave setup, installed and started up by people

authorized by the manufacturer.

Never operate the autoclave in explosive atmospheres.

The connections for electrical provision and water supply and draining

must be set-up by trained personnel.

The device is designed for use outside patient surroundings. It should be

located at least 1.5 m away (radius) from the treatment area.

If the device comes with a printer, the printer must be placed in such a

way that it will not contact with liquids.

Emergency

Door Open Do not use this emergency device under normal circumstance.

Decontami-

nation and

sterilization

Follow the manufacturer instructions of instrument and textiles

regarding their decontamination and sterilization.

Observe the relevant standards and directives for the decontamination

and sterilization of instruments and textile, e.g. RKI and DGSV.

Only use packaging material and holders which have been approved by

their manufacturer for steam sterilization.

Program

termination

Please observe that depending on the time of the program abort, opening

the door following a program abort can lead to hot steam leaving the

chamber.

Depending on the time of the program abort, it is possible that the load

is unsterile. If necessary, rewrapping and sterilize the affected objects.

Removal of

the items

sterilized

Never use force to open the door.

Use a tray holder to remove the tray. Never touch the sterilized items,

the chamber or the door with bare hands.

Check the wrapping of the sterilized objects for damage when removing

them from the autoclave. If a wrapping is broken, re-pack the objects

and re-sterilize it.

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IV

Transport

and storage

The device should always be carried by 2 people.

Use suitable carrying straps to carry the device.

Install and operate the device in a frost-free environment.

Maintenance

Have the maintenance done only by authorized personnel.

Comply with the predetermined maintenance intervals.

Only original HäTmed spare parts may be used.

Errors

Should the device issue the same malfunction message repeatedly, turn

off the device.

Only have the device repaired by authorized personnel.

Sterilization Programs:

Program Name GEN 134

GEN 121

QuickB

Quick S 134+ Prion Fabric

Dynamic pressure test of the sterilization chamber

√ √ √ √ √ √ √

Air leak √ √ √ √ √ √ √

Empty chamber √ √ √ √ √ √ √

Solid load √ √ √ √ √ √ Solid and porous load √ √ √ √

Porous partial load √ √ √ √ √

Porous full load √ √ √ √ √

Hollow body B √ √ √ √ √ √

Hollow body A √ √ √ √ √

Simple wrapping √ √ √ √ √ √ √

Multiple wrapping √ √ √ √ √ √

Drying, solid load √ √ √ √ √ √

Drying, porous load √ √ √ √ √ Sterilization temperature 134 °C 121 °C 134 °C 134 °C 134 °C 134 °C 121 °C

Sterilization pressure 2.1 bar 1.1 bar 2.1 bar 2.1 bar 2.1 bar 2.1 bar 1.1 bar

Sterilization time 5.5min 16min 3.5min 3.5min 5.5min 20min 20min

Note:√= Conformity with all applicable sections of the standard EN 13060

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V

Contents

1 Device Description ............................................................................................................................ - 1 - 1.1 Scope of delivery ....................................................................................................................... - 1 -

1.1.1 Standard accessories ........................................................................................................... - 1 - 1.1.2 Optional accessory ............................................................................................................... - 2 -

1.2 Views of the device .................................................................................................................... - 3 - 1.2.1 Front view ............................................................................................................................. - 3 - 1.2.2 Side view............................................................................................................................... - 3 - 1.2.3 Rear view .............................................................................................................................. - 4 - 1.2.4 Interior view .......................................................................................................................... - 4 -

1.3 Technical data ............................................................................................................................ - 4 - 1.4 Mountings for the load .............................................................................................................. - 6 - 1.5 Intelligent controller and the control panel ............................................................................. - 6 -

1.5.1 The control panels ................................................................................................................ - 6 - 1.5.2 Status symbols and command keys in the user interface .................................................... - 7 -

1.6 Emergency door handler ........................................................................................................... - 7 - 1.7 Program sequences ................................................................................................................... - 8 -

1.7.1 Regular sterilization program ................................................................................................ - 8 - 1.7.2 Vacuum test .......................................................................................................................... - 8 -

2 Installation and Transportation ....................................................................................................... - 9 - 2.1 Unpacking the device ................................................................................................................ - 9 - 2.2 Set-up location requirements ................................................................................................... - 9 - 2.3 Adjust height for the device .................................................................................................... - 10 - 2.4 Connections required .............................................................................................................. - 10 -

2.4.1 Power connection ............................................................................................................... - 10 - 2.4.2 Feed water supply .............................................................................................................. - 10 - 2.4.3 Waste water draining .......................................................................................................... - 11 - 2.4.4 Printer connection (Optional) .............................................................................................. - 11 -

2.5 Record of Installation .............................................................................................................. - 12 - 2.6 Transportation .......................................................................................................................... - 12 -

3 Getting started ................................................................................................................................. - 13 - 3.1 Switching on the device .......................................................................................................... - 13 - 3.2 After switching on .................................................................................................................... - 13 -

3.2.1 Pressure calibration ............................................................................................................ - 13 - 3.3 Door operation ......................................................................................................................... - 14 -

4 Sterilization ...................................................................................................................................... - 15 - 4.1 Load the autoclave .................................................................................................................. - 15 - 4.2 Select program ......................................................................................................................... - 15 - 4.3 Additional program options .................................................................................................... - 16 -

4.3.1 Automatic pre-heat ............................................................................................................. - 16 - 4.3.2 Automatic printing ............................................................................................................... - 16 - 4.3.3 Additional drying ................................................................................................................. - 17 - 4.3.4 Start time pre-set ................................................................................................................ - 17 -

4.4 Running the cycle .................................................................................................................... - 18 - 4.4.1 Start the cycle ..................................................................................................................... - 18 - 4.4.2 Program execution .............................................................................................................. - 18 -

4.5 Manual program abort ............................................................................................................. - 18 - 4.6 Program complete ................................................................................................................... - 19 - 4.7 Storing sterile instruments ..................................................................................................... - 20 -

5 Function tests and other programs............................................................................................... - 21 - 5.1 Vacuum test .............................................................................................................................. - 21 - 5.2 Bowie &Dick Test ..................................................................................................................... - 22 - 5.3 Helix test ................................................................................................................................... - 22 - 5.4 Drain program .......................................................................................................................... - 22 - 5.5 Reliability test ........................................................................................................................... - 23 -

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VI

5.6 User defined program .............................................................................................................. - 23 - 6 Settings ............................................................................................................................................. - 24 -

6.1 Date and time ............................................................................................................................ - 24 - 6.2 Language .................................................................................................................................. - 24 - 6.3 Device information ................................................................................................................... - 25 - 6.4 Cycle information ..................................................................................................................... - 25 - 6.5 Advanced settings ................................................................................................................... - 25 -

6.5.1 Automatic pre-heat .............................................................................................................. - 26 - 6.5.2 Automatic printing ............................................................................................................... - 26 - 6.5.3 Water quality check ............................................................................................................. - 27 - 6.5.4 Additional drying .................................................................................................................. - 27 - 6.5.5 Change user password ....................................................................................................... - 27 - 6.5.6 System reset ....................................................................................................................... - 28 - 6.5.7 User defined program configuration .................................................................................... - 28 -

7 Logging ............................................................................................................................................. - 29 - 7.1 Find logs ................................................................................................................................... - 29 - 7.2 Export logs ................................................................................................................................ - 29 - 7.3 Print logs ................................................................................................................................... - 30 - 7.4 Read a log file ........................................................................................................................... - 31 -

8 Maintenance ..................................................................................................................................... - 32 - 8.1 Cleaning and preparation of the sterilization load ............................................................... - 32 - 8.2 Maintenance of the device....................................................................................................... - 32 -

8.2.1 Cleaning .............................................................................................................................. - 32 - 8.2.2 Maintenance ........................................................................................................................ - 33 -

9 Warnings and errors ....................................................................................................................... - 34 - 9.1 Warnings and errors ................................................................................................................ - 34 - 9.2 Common issues and troubleshooting .................................................................................... - 36 -

9.2.1 Screen No Display .............................................................................................................. - 36 - 9.2.2 Large Consumption of Distilled Water ................................................................................ - 37 - 9.2.3 Load not dried sufficiently ................................................................................................... - 37 - 9.2.4 No Distilled Water ............................................................................................................... - 37 - 9.2.5 Leaking air or water at the door opening ............................................................................ - 37 - 9.2.6 Cannot open the door ......................................................................................................... - 37 -

Appendix 1 Safety mechanism ........................................................................................................... - 38 - Appendix 2 Block diagram .................................................................................................................. - 39 - Appendix 3 Electrical diagram ............................................................................................................ - 40 -

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1 Device Description 1.1 Scope of delivery 1.1.1 Standard accessories

Following accessories are supplied together with the autoclave.

STANDARD ACCESSORIES

Accessory Symbol Quan-tity Description

Gradient

1

Place it on top of the device while setting it up. Observe the gradient while adjusting the foot pads. Ensure that the front of the device is higher than the rear. A proper position is while the angle between the bottom of the device and table is about 30°C.

Tray

3 Perforated anodized aluminum tray

Tray holder

1 Tray holder for removing tray from the sterilization chamber

Mounting rack

1 Stainless steel rack to accommodate trays

Distilled water pipe

1 Φ4*6 2M transparent silicone pipe for feeding distilled water

Drain pipe

1 Heat-resist drain pipe with female thread connector

Fuse

2 250V/20A Fuse

Air filter

1 High efficiency air filter to block dust and bacteria from entering into the chamber

Emergency door open tool

1 Tool for opening the door in case of emergency such

as power outage

DOCUMENTS

User Manual

1 This Manual

Service Handbook 1 Installation guide; installation service record sheet;

maintenance record sheet.

Notice 1 Common issues and things need users’ attention

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1.1.2 Optional accessory

Mini thermosensitive printer

Only use original HäTmed accessories. Consult manufacturer

before using other accessories. Use of unauthorized accessories

may cause unsuccessful sterilization or failure to function. Accessory equipment connected to analog and digital interfaces

must be certified according to the respective EN/IEC standards.

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1.2 Views of the device 1.2.1 Front view

Figure 1.1 Front view

1.2.2 Side view

Figure 1.2 Side view

Screen

Jog-dial Knob

Power switch

Air filter

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1.2.3 Rear view

Figure 1.3. Rear view

1.2.4 Interior view

Figure 1.4 Interior view

1.3 Technical data

Device type A50B A60B A70B

Test I/O

USB

Printer

Emergency Open

Power cable

Air filter

Safety valve

Drain outlet

Distilled water inlet

Fan

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Device dimensions 625mm*485mm*330mm 805mm*485mm*330mm 830mm*485mm*330mm

Packaging dimensions 725mm*585mm*430mm 905mm*585mm*430mm 930mm*585mm*430mm

Chamber size 336mm*240mm*144mm 516mm*240mm*144mm 636mm*240mm*144mm

Chamber volume 10 L 15 L 18 L

Pressure vessel weight 9.5 kg 14.5 kg 15.5 kg

Device empty weight 54.2 kg 60 kg 64.8 kg

Electricity supply 230V/50Hz

Power consumption 2800VA

Built-in fuses 250V/20A

Ambient pressure 70 Kpa ~ 106 Kpa

Ambient temperature 5 oC ~ 40 oC Temperature for

transport and storage -20 oC ~ 55 oC

Humidity ≤ 85%

Max. instrument load 3.3 kg 4.8 kg 6.6 kg

Max. textile load 0.75 kg 1.1 kg 1.5 kg

Memory size 16M Byte

Distilled water quality Distilled or demineralized water according to EN 13060 Appendix C

Distilled water pressure ≤ 30 Kpa Max. distilled water

consumption 725 ml 800 ml 910 ml

Max. waste water temperature 95 oC

Noise emission 70 dB(A)

Length of power cable 1.8 m

IO input voltage 5V

Transient Over-Voltage Category II Pollution Degree

Rating II

Electromagnetic Compatibility

Comply with IEC61326-1-2005; No interference is caused by this device to its environment while it can continue to function in the presence of electromagnetic disturbances of specified level.

Conformity EN13060-2014; EN61010-1; EN61010-2-040

Note 1:The maximum voltage range is 200V ~ 250V

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1.4 Mountings for the load The autoclave is delivered with a mounting rack. The space inside the mounting rack is the space that can be

sterilized effectively. Hence the rack must be used while loading the autoclave. The mounting rack can hold 3 trays.

Figure 1.5 Mountings of load

1.5 Intelligent controller and the control panel The controller is the core of the autoclave. It not only accomplishes real-time parameters acquisition,

processing, fault detection and control of a sterilization process, but also accurately depicts the graph of temperature

and pressure that change over time. The controller is also responsible for the assessment and monitoring of the

program control process. During the sterilization period, it will compare the running parameter with the standard

parameter, once the running parameter deviates from the standard, it will generate fault messages immediately, and

ensure the safety and quality of the sterilization.

The system offers convenient and simple operation through a colored 3.5 inch display and a jog-dial knob.

1.5.1 The control panels

In the control panels, system status bar is on the top and displays time, task, door lock status and external

storage device status. The main interface in the middle displays different contents depending on various tasks or

conditions. The bottom portion contains command keys for operations.

Figure 1.6 Control panel

System Status Bar

Main Interface

Command keys

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1.5.2 Status symbols and command keys in the user interface

Status Symbol Function

Door lock Door lock status: open or closed

External storage External storage status: connected or not

Pressure meter Pressure reading in the chamber

Temperature meter Temperature reading in the chamber

Timer Time elapse after start current program

Program stage Current program stage (e.g. pre-vacuum,

heating, sterilization, drying)

Command key Function

Open Unlock and open the door

Start Start current selected program

Print Print record

Schedule Set a time for running a program

automatically

Back Go back to upper level menu

Export Export records to external storage

Confirm Confirm previous input

Cancel Cancel previous input

1.6 Emergency door handler The emergency door handler at the rear of the device can be used when there is an electrical power failure or

an issue with the safety door lock system. Do not use this handler under normal circumstances. Care must be taken

to ensure there is no pressure in the chamber before using the emergency door handler.

Operation method: uninstall the screw on the Emergency cap, fit the emergency door open T-wrench on the

shaft and turn counter clockwise until the door is open.

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1.7 Program sequences 1.7.1 Regular sterilization program

A program runs in 3 phases, air removal, sterilization and drying phase. After program starts, the user can

follow the program running status on the display. It shows the chamber temperature and pressure as well as time

elapsed for the current running program.

Program Phase Description

1.Air removal

The air removal phase comprises the conditioning and the evacuation. During

conditioning, steam is repeatedly injected into the sterilization chamber to

generate over-pressure. During evacuation, the mixture of air and steam is

then removed repeatedly. This procedure is also called the fractionated pre-

vacuum procedure. Number of pre-vacuum fraction varies from program to

program. GEN134 is set for 3 times of pre-vacuum fraction and Helix or 134+

is set for 4 times.

2.Heating

The heating phase follows the air removal phase. Steam continuously entering

into the chamber leads to an increase in pressure and temperature until the

program-specific sterilization parameters are reached.

3.Sterilization

Sterilization phase begins when pressure and temperature match the pre-set

nominal values. Sterilization phase ends when pressure and temperature are

maintained for a period of time that is program-specific.

4.Pressure release After sterilization phase, pressure releases by evacuating steam from

chamber.

5.Drying Drying phase begins after pressure release. The load is dried using a vacuum.

During drying the air filter ensures sterile environment in the autoclave.

6.Ventilation Ventilation happens during drying phase. Upon program end, the chamber

pressure is adapted to the ambient pressure.

1.7.2 Vacuum test

The purpose of vacuum test is to measure the leakage rate of the autoclave. No sterilization is performed during

vacuum test. Please run vacuum test with a cold, dry and empty autoclave.

Program phase Description

1.Air removal Air is evacuated until the pressure in the chamber reaches the pre-set value.

2.Equilibration An equilibration time of 5 minutes.

3.Measurement Measurement time of 10 minutes during which pressure in the chamber is

monitored and displayed.

4.Test end The screen shows the test result: leakage rate

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2 Installation and Transportation 2.1 Unpacking the device

Only have the autoclave setup, installed and started up by people

authorized by the manufacturer.

If this autoclave had been kept in a different location from the

installation site, wait for an appropriate time before installing and

switching ON the autoclave. Autoclaves arriving from cold

locations could contain moisture that affects the electrical parts

and it could lead to unsafe operation for user and the device.

The autoclave must be removed from the box and transported by

2 people.

Total weight:A50B 54.2 kg; A60B 60 kg; A70B 64.8 kg

Check the external condition of the package and the autoclave. In

case of any damage, contact the distributor or the transporter

immediately.

Please check all accessories in the box and the chamber of the

autoclave according to the accessary table in Section 1.1 of this

User Manual.

2.2 Set-up location requirements Set up the autoclave in a dry and dustproof location. The air humidity should be lower than 85% and the

ambient temperature 5 oC to 40 oC.

Never setup or operate the autoclave in explosive atmospheres.

The autoclave is designed for indoor use only.

The position of the autoclave should be easy to access for

disconnection or termination of operation.

The workbench must be able to support the device weight: A50B 54.2 kg; A60B 60 kg; A70B 64.8 kg

The distance from each side of the autoclave to the surrounding

surfaces must be at least 10 cm. Failure to follow these guidelines

may lead to heat accumulation and adversely affect the function of

the autoclave and could shorten the lifetime of the vacuum pump

and increase cycle time.

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2.3 Adjust height for the device Find the gradient in the accessary bag and place it on top of the device. Observe the gradient while adjusting

the two foot pads in front. Ensure that the front of the device is higher than the rear. A proper position is while the

angle between the bottom of the device and table is about 5°-10° which is beneficial for drying of sterilization load

and minimizing distilled water consumption.

Figure 2.1 Adjust height for the device

2.4 Connections required 2.4.1 Power connection

Power supply of 230V/50Hz. Max. voltage range of 200V ~ 250V

Dedicated 16A power outlet. Protection from leakage current

30mA.

Make sure the power cable is not knotted or jammed (e.g. between

the doors or windows)

Never unplug by pulling on the power cable. Always take hold of

the power plug itself.

Never lead the cable along a source of heat.

Never use sharp objects to fix the cable.

Never change the main cable or power plug. Never use a damaged

power cable or plug.

Never operate the device if the plug or power cable is damaged.

The power cable and plug should only be replaced by authorized

personnel.

2.4.2 Feed water supply

The autoclave does not come with internal water reservoirs. An external water container is needed. Take out

the distilled water pipe from the accessary bag. Put the end with filter inside the distilled water container and

connect the other end to the distilled water inlet at the rear of this autoclave (Fig. 1.3). Fill the contained with

fresh distilled water before operating the autoclave.

Front Rear

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Use distilled or demineralized water that meets the requirements

listed in EN 13060 Appendix C. Unqualified feed water may cause

corrosion of instruments;

Conductivity ≤20μs/cm;

Feed water pressure ≤ 30 Kpa;

A 12L container can supply distilled water to the autoclave for more

than 20 cycles. Please pay attention to the water level in the

container and fill it in time to avoid program abort due to no

distilled water;

The cap of the distilled water contained must always be screwed

tight to ensure cleanness of the feed water;

Please clean the container at least once in a month;

This device has water quality monitor. When fed with unqualified

water, the autoclave will not work properly and but give warnings

about water quality. Please change high quality distilled water

immediately upon seeing the warning message;

Please consult the manufacturer before using a water treatment unit.

All water pipes connected at the rear of the autoclave are

recommended to face downward and fixed firmly without bend or

knot.

2.4.3 Waste water draining

Take out the drain pipe from the accessory bag. Connect it to the waste water outlet at the rear of the

autoclave (Fig.1.3) and fix it tightly. Put the other end to the waste water sink.

All water pipes connected at the rear of the autoclave are

recommended to face downward and fixed firmly without bend or

knot.

2.4.4 Printer connection (Optional)

Take out the power cable and data line from the printer package. Connect the data line from the printer to the

DB9 connector at the rear of the autoclave (Fig. 1.3) and screw it tightly. Connect the original power cable that

comes with the printer to supply power. Load paper roll before switch on the printer. The power switch of the

printer is at the rear side of the printer.

Please use the original power cable that comes with the printer;

Status light (Red) ON indicates lack of paper;

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The autoclave has built-in memory that can store up to 4000

sterilization records. Sterilization records can be exported to

external portable storage device any time through USB I/O

(Fig. 1.3)

2.5 Record of Installation

As documentation of proper installation as well as for warranty

claim, the record of installation must be filled by person

responsible.

2.6 Transportation This device must be stored and transported in an environment that has air humidity level lower than 85% and

ambient temperature -20 oC ~ 55 oC.

Before moving the autoclave, please run the drain program first. Then take off all pipes at the rear of the device

(distilled water pipe and waste water pipe). If a printer is connected, please disconnect the printer data line as well.

If the mounting rack and trays are placed in the chamber during the move, please put foam between the rack

and chamber door to avoid abrasion or damage.

If the autoclave need to be transported for long distance, it must be put back to its original package. Please

make sure the box is sealed carefully after loading the autoclave.

Please run drain program to drain residue water in it before

moving or transporting the device.

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3 Getting started 3.1 Switching on the device

To power on the autoclave press the power switch located at the bottom left corner of the device (Fig. 1.4)

Please remove the latex plug inside the air filter opening at the rear

of the autoclave (Fig. 1.3) before switching on the device and install

the air filter in the accessory bag.

3.2 After switching on

After switching on, please follow the system prompts to setup language, time, date and calibrate ambient

pressure. After successfully calibrate ambient pressure, the control panel will prompt operation to enter the main

menu. For setting up language, time and date during normal use, please refer to Chapter 6 of this User Manual.

Figure 3.1 Flow for initial setup

3.2.1 Pressure calibration

During initial setup, the autoclave will prompt pressure calibration to set the pressure baseline according to

ambient pressure at the location of installation. Door must be open during pressure calibration. Please follow the

system prompt to open the door before pressure calibration. Initial setup is complete when pressure calibration

succeeds. After a period of time, particularly if the autoclave is moved to somewhere else, pressure calibration

must be performed again. For pressure calibration during normal use, please refer to Section 6.5.6 in this User

Manual.

Welcome

Language Setting

Time Setting

Pressure Calibration

Main Menu

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Figure 3.2 Pressure Calibration

3.3 Door operation

Opening the door: If door open icon is shown in the user interface, rotate the jog-dial to and press 【Open】

icon (Fig. 3.3), the door will open automatically. If the current interface does not have door open icon, go back to

the main interface (Fig. 3.1), rotate the jog-dial to sterilization and press it to enter. Select a program to enter and

rotate the knob to door open icon. Press the jog-dial to open the door. The door lock status icon in system status

bar will change to unlock indicating door unlocked.

Figure 3.3 Door open icon

Closing the door: Move the door toward the chamber, when it is close enough, the motor-driven spindle

automatically close the door. The door locks pressure-proof once a program starts.

Under no circumstance should you slam the door shut.

Failure to follow the above instructions may impair the functional

reliability of the door lock mechanism.

Leave the door open only for loading and unloading the autoclave.

Keeping the door close helps energy saving.

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4 Sterilization 4.1 Load the autoclave

Mounting rack and trays are standard accessories that come with the autoclave. Only the space framed by the

rack is effective sterilization space. The outer rim of the chamber is too close to the chamber wall, hence loads may

get wet or scorched. Please use the original mounting rack and trays that have ventilation holes at the base.

Proper loading is the key to effective sterilization and good drying

results. The below instructions must be followed carefully to load the

autoclave properly:

Only use packaging materials and systems which meet EN 868

standard;

While sterilizing instruments wrapped in plastic paper pouches, the

paper side must be facing upward;

While sterilizing mixed loads, always place textiles at the top;

Leave sufficient room between pouches;

The total loaded space should not exceed 90% of the chamber

space.

4.2 Select program

In main interface (Fig.3.1), rotate the jog-dial to sterilization and press to enter the program selection interface

(Fig.4.1). Select program by rotating the jog-dial and press to enter specific program.

Figure 4.1 Program selection interface

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The autoclave offers 7 pre-defined sterilization programs and 2 user-defined programs. Please select the

sterilization program accordingly depending on whether and how the sterilization loads are wrapped. Furthermore,

consider the resistance to high temperature of the items to be sterilized. The following table show which program

to choose for what items to be sterilized in A70B. A50B and A60B only varies in max. load weight from A70B.

The max. load weight for A50B is 3.3 kg instruments or 0.75 kg textiles. The max. load weight for A60B is 4 kg

instruments or 1.1 kg textiles.

Table 4-1 A70B Sterilization programs and load description

4.3 Additional program options 4.3.1 Automatic pre-heat

The automatic pre-heating function heats the autoclave chamber to a program-specific pre-heated

temperature before the program start, or holds this temperature between two program runs. This will shorten the

cycle times. For setting automatic pre-heating, please refer to Section 6.5.1.

After switching on the automatic pre-heating function, the autoclave will

heat up the chamber automatically to 110℃. Please take caution to avoid

burns!

4.3.2 Automatic printing

If automatic printing is switched on and printer is connected to the device correctly, the system will print

record automatically after the program completes. For setting automatic printing, please refer to Section 6.5.2 in

this User Manual.

Program Temp

(℃)

Sterilization

(min)

Drying

(min)

Max. cycle

time (min) Typical load

Max.

load

weight

GEN121 121 16 20 28-50 Textile load up to 1.5 kg or heat resistant instruments up to 6.6 kg.

1.5 kg /6.6kg

GEN134 134 5.5 15 15-40 Mixed load. Hollow instruments etc. 6.6kg

134+ 134 5.5 15 17-42 Mixed load. Hollow instruments etc. 6.6kg

Quick S 134 3.5 2 12-18 Solid instruments, simple geared or hollow instruments. 6kg

Quick B 134 3.5 6 14-20 Wrapped instruments up to 4 kg or 6.6 kg unwrapped solid instruments.

4 kg /6.6 kg

Prion 134 20 15 36-55 Materials that are suspicious to Prion disease. 6.6 kg

Fabric 121 20 20 38-60 Textile loads of up to 1.5 kg. 1.5kg

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4.3.3 Additional drying

The autoclave offers additional drying function for users that prefer better drying results at the cost of longer

drying time. If additional drying is set, the drying time listed in Table 4-1 will be extended. This function is

particularly useful for drying large amount of textile loads. For setting additional drying, please refer to Section

6.5.7 in this User Manual.

4.3.4 Start time pre-set

The autoclave allows users to select any program and start it at a pre-set time. After setting pre-set start time

for a selected program, an alarm clock icon will be shown in grey area in the top of the main interface. The

autoclave must be switched on at the pre-set time, otherwise the pre-set start time expires. If the autoclave is

powered on, the selected program will start automatically at the pre-set time. Pre-set start time is configured in

sterilization program interface. For example, if Gen134 is the selected program, first select Gen134 in the program

selection interface (Fig. 4.1). The screen displays program introduction interface (Fig. 4.2 left). Rotate the jog-dial

to the clock icon and press to enter the pre-set start time configuration interface (Fig. 4.2 right). In the pre-set start

time configuration interface, set the start time and confirm the settings by pressing 【√】.

Figure 4.2 Pre-set time and program start

Unsupervised operation of this autoclave is at the operato

HäTmed accepts no liability what so ever for any damag

resulting from unsupervised operation.

Please take caution of the following notes after pre-set start tim

The autoclave should be powered on;

Distilled water pipe is properly connected and distilled w

container has sufficient water;

Waste water pipe are connected properly.

Items to be sterilized are properly loaded and autoclave d

closed.

Start

Pre-set time

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4.4 Running the cycle 4.4.1 Start the cycle

After entering the program introduction interface (Fig. 4.2), rotate the jog-dial to【Start】and press to

confirm. The autoclave will check the door lock status and water quality before running the selected program.

4.4.2 Program execution

A program runs in 3 phases, the air removal phase, sterilization and drying. Please refer to Section 1.6.1 of

this User Manual for explanation of each phase. The screen displays real-time chamber temperature and pressure

as well as time information of the cycle, as shown in Fig. 4.3.

Figure 4.3 Program execution

4.5 Manual program abort A program can be aborted in all phases. If program ends before drying begins, the sterilization load is

unsterile. Otherwise, the items have been sterilized but not sufficiently dried. In full load case, it is highly possible

for wet pack to occur. These wet packs cannot be stored because sterile storage set high requirements on the level

of dryness.

Hot steam can be released from the autoclave when opening the

door after a program abort. This could result in burns!

Never touch the sterilized instruments, the chamber or the door

with bare hands. These components are hot!

Always use a tray handle or proximity gloves to remove the trays.

Danger of infection from early program abort!

Aborting a program before the drying phase begins means that the

load is unsterile. This endangers the health of your patients and

the operator;

If necessary, repack the load and repeat the sterilization.

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If manual abort is necessary, rotate the jog-dial and press 【Stop】in the screen (Fig. 4.4 left). After the

program is manually aborted, the screen prompts error messages and displays program ending interface (Fig. 4.4

right). The intelligent controller keeps monitoring temperature and pressure in the chamber and status of other

components of the device. The controller will only allow the user to open the door when it is safe to do so.

Usually it takes a few minutes for the device to reach the stage.

4.6 Program complete After a program runs successfully to the end, the screen displays program complete interface and program

success message (Fig. 4.5). If automatic printing is set and the printer is connected correctly, the autoclave will

print the sterilization record automatically. Rotate the jog-dial to 【Open】icon and press it to open the door.

Figure 4.5 Program complete

Danger of burns from hot surfaces and hot steam!

Never use force to open the door. This could damage the device

and /or result in the emission of hot steam;

Allow the autoclave to cool sufficiently before opening;

Figure 4.4 Manual abort

Stop Open

Open

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Do no touch any hot metal parts;

Never touch the sterilized instruments, the chamber or the door

with bare hands.

Always use a tray handle or proximity gloves to remove the trays. Hold the mount level when removing it from the chamber.

Otherwise, the load could slide off.

Damaged or burst packaging lead to unsterile instruments. This

endangers the health of patients and operators.

Should the packaging be damaged or have burst, re-pack and re-

sterilize the items.

Leaving the sterilized items in the chamber for 5 min after the

program completes is beneficial for dryness of the sterile packs;

According to the AKI (red brochure 10. Edition; S.57), residual

moisture in the form of a few drops of water capable of evaporating

within 15 min is tolerated, but actual pools of water are not

acceptable.

It is recommended to keep records of every cycle for further

reference. In some countries, it is mandatory to do so.

4.7 Storing sterile instruments

The maximum storage time is dependent on the packaging and the storage conditions. For standard-conform

packaged sterilized instruments, if protected from dust, it can amount to up to six months. Comply with the

provisions of DIN 58953, part 8 and the criteria specified below for the storage of sterilized instruments.

Comply with the maximum storage duration in accordance with the

packaging type;

Do not store the sterilized instruments in the decontamination area;

Store the sterilized instruments in dustproof, dry (free from moisture,

alcohol, disinfectant etc), temperature controlled environment.

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5 Function tests and other programs 5.1 Vacuum test

Please run a vacuum test to check leakage rate at first time use, after long idle time or moving to a new

location and during regular maintenance check. Choose 【Test】in the main interface (Fig. 3.1) to enter test

program interface. Rotate the jog-dial to select【Vacuum Test】and press to enter vacuum test introduction

interface. Rotate the jog-dial to 【Start】and press to run vacuum test.

Figure 5.1 Test program interface

Please run the vacuum test with cold, dry and empty chamber;

Please ensure the autoclave door is locked tightly and cooling

water tap is on; It is recommended to run Vacuum test once weekly in routing

operations.

At the beginning of the vacuum test, air is extracted out from the chamber and pressure inside the chamber

drops. When the pressure in the chamber reaches program-specified value, vacuuming stops. This is followed by 5-

min balance time and 10-min vacuum test. During the test, the screen displays real-time pressure in the chamber.

The autoclave returns to ambient pressure after the vacuum test. Test record is stored in the built-in memory. If

automatic printing is set and a printer is installed, the test record will be printed automatically too.

If test passed, the screen prompts “Vacuum test succeed”, which means that leakage rate of the system meets

design requirement. The printed message is as below: - - - - - - - - - - - - - - -

PROGRAM PROPERLY EXECUTED! Test passed! Leakage rate: <0.13Kpa/min Leakage: <0.13Kpa/min

Your system is steady! - - - - - - - - - - - - - - - If test failed, the screen prompts “Vacuum test fail”. The printed message is as below: - - - - - - - - - - - - - - - PROGRAM PROPERLY EXECUTED! Test failed! Vacuum Test Fail! - - - - - - - - - - - - - - -

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If vacuum test failed, please stop using this autoclave and contact

distributor or manufacturer immediately.

5.2 Bowie &Dick Test

The Bowie & Dick test serves as the proof of steam penetration for porous materials such as textiles. Choose

【B&D Test】in test program interface (Fig. 5.1).

Conduct the test and interpret test results according to the

manufacturer’s instruction of the test pack;

It is recommended to run B&D once weekly in routing operations.

5.3 Helix test Helix test serves as the proof of steam quality (saturation) and penetration for hollow A instrument, such as

dental hand-piece. Choose 【Helix Test】in test program interface (Fig. 5.1).

Conduct the test and interpret test results according to the

manufacturer’s instruction of the test pack.

5.4 Drain program

The autoclave provides drain program to discharge residual water inside the autoclave. Choose 【Drain

Program】in functional program interface (Fig. 5.2).

Figure 5.2 Functional program interface

If water is ponding in the chamber when you open the door, please

run drain program before loading items to be sterilized. If last

program was aborted in the middle way, it is possible that

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significant amount of water is left in the chamber. Please open the

door to check after program abort;

Please run drain program before moving or transporting the

device.

5.5 Reliability test The autoclave features with reliability test for safety check of the system during regular maintenance or

routing operation. Choose 【Reliability Program】in functional program interface (Fig. 5.2).

5.6 User defined program

The autoclave offers 2 user defined programs – User-1 & User-2. Users can configure these programs based

on particular need or personal preference. Configurable parameters include sterilization temperature, number of

times of pre-vacuum, sterilization time and drying time.

Configure the user defined programs following Section 6.5.8 of this User Manual. After configuration,

choose 【Sterilization】in main interface (Fig.3.1) to access program selection interface (Fig. 4.1). Rotate the

jog-dial to choose 【User-1】or【User-2】. Operations to run these programs are same as to run pre-set

sterilization programs, as described in Section 4.4 of this User Manual.

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6 Settings Rotate the jog-dial to 【Setting】in main interface (Fig. 3.1) and press to enter system settings interface

(Fig. 6.1). Users can set date, time and language or check device information and cycle information.

Figure 6.1 System settings

6.1 Date and time

Rotate the jog-dial to 【Time and Date】in system settings interface (Fig. 6.1) and press to enter date and

time setting interface. Rotate the jog-dial to set the correct year, month, date, hour and minute, then rotate to and

press 【√】to confirm.

6.2 Language

Rotate the jog-dial to 【Language】in system settings interface (Fig. 6.1) and press to enter language setting

interface. Choose language, then rotate to and press 【√】to confirm.

Figure 6.2 Date and time setting Figure 6.3 Language setting

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6.3 Device information Device information page displays serial number of the device and its hardware and software versions. Rotate

the jog-dial to and press【Dev info】in system settings interface (Fig. 6.1) to enter device information interface

(Fig. 6.2). When finish reading, rotate to and press 【√】to confirm and the screen will return to system settings

interface.

6.4 Cycle information Cycle information displays the total number of cycles the autoclave have run. Rotate the jog-dial to and press

【Work info】in system settings interface (Fig. 6.1) to enter cycle information interface (Fig. 6.3). When finish

reading, rotate to and press 【√】to confirm and the screen will return to system settings interface.

Figure 6.4 Device info Figure 6.5 Cycle info

6.5 Advanced settings Advanced settings include automatic pre-heat, automatic printing, water quality check, additional drying,

system reset, user password reset, and user defined program configuration. To ensure sterilization quality and safe

operation of the autoclave, settings and configurations of sterilization parameters or special features are protected

by password. User must enter password to access the advanced settings.

Rotate the jog-dial to and press 【Advanced】in main interface (Fig. 3.1) and key in factory default user

password “111111” to enter advanced settings interface (Fig. 6.6).

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Figure 6.6 Advanced settings

6.5.1 Automatic pre-heat

Rotate the jog-dial to and press 【Auto Preheat】in advanced settings interface (Fig. 6.6) to enter automatic

pre-heat setting interface (Fig. 6.7). Choose 【ON】or 【OFF】, then rotate to and press【√】to confirm.

After switching on the automatic pre-heating function, the autoclave will

heat up the chamber automatically to 110℃. Please take caution to avoid

burns!

6.5.2 Automatic printing

Rotate the jog-dial to and press 【Auto Printer】in advanced settings interface (Fig. 6.6) to enter automatic

printing setting interface (Fig. 6.8). Choose 【ON】or 【OFF】, then rotate to and press 【√】to confirm.

Figure 6.7 Automatic printing Figure 6.8 Automatic printing

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6.5.3 Water quality check

Rotate the jog-dial to and press 【Water Quality】in advanced settings interface (Fig. 6.6) to enter water

quality check setting interface (Fig. 6.9). Choose 【ON】or 【OFF】, then rotate to and press 【√】to confirm.

6.5.4 Additional drying

Rotate the jog-dial to and press 【Extra dry】in advanced settings interface (Fig. 6.6) to enter additional

drying setting interface (Fig. 6.10). Choose 【ON】or 【OFF】, then rotate to and press【√】to confirm.

Figure 6.9 Water quality check Figure 6.10 Additional drying

6.5.5 Change user password

Rotate the jog-dial to and press 【Change UsrPwd】in advanced settings interface (Fig. 6.6) to enter user

password reset interface (Fig. 6.11). Key in the factory default password “111111” in “Old Pwd” box and new

password of your own in “New Pwd” box. Rotate to and press 【√】to proceed and system will prompt to

confirm the new password. Rotate to and press 【√】to complete the user password reset.

Figure 6.11 Change user password

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6.5.6 System reset

Rotate the jog-dial to and press 【System reset】in advanced settings interface (Fig. 6.6) to enter system

reset interface (Fig. 6.12). Rotate to and press 【√】, the autoclave will be restored to its factory default settings.

Figure 6.12 System reset

6.5.7 User defined program configuration

Rotate the jog-dial to 【User defined -1】or 【User defined -2】in advanced settings interface (Fig. 6.6)

and press to enter user defined program configuration interface (Fig. 6.13). Set sterilization temperature, number

of times of pre-vacuum, sterilization time and drying time, then rotate to and press 【√】to confirm.

Figure 6.13 User defined program configuration

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7 Logging The autoclave records and stores real-time data of the sterilization process. The built-in memory of this

device can store records up to 4000 cycles. Log file is named after cycle number, e.g. 00001.TXT. These logs can

be exported to portable USB disk or printed via a mini printer.

7.1 Find logs Rotate the jog-dial to【Log】in main interface (Fig. 3.1) and press to enter log interface (Fig. 7.1). Choose a

time period or【Inquire Records】to enter dates input interface (Fig. 7.2). After selecting the dates, the screen

will list all logs of those dates (Fig. 7.3).

Figure 7.1 Log interface Figure 7.2 Select by date Figure 7.3 Select logs

7.2 Export logs For permanent storage of sterilization records, all logs can be exported through the USB interface to a computer

or other portable storage device. To operate: Insert the USB disk into the USB interface. Rotate the jog-dial to the

specific log in log select interface (Fig. 7.3) and press to select. Rotate the jog-dial to【Export】icon and press it.

A progress bar appears to indicate the export process (Fig.7.4). When it reaches 100%, the screen will prompt

“Export Succeed”. The USB disk can be removed.

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Figure 7.4 Log export progress

7.3 Print logs Rotate the jog-dial to and press to select log in log select interface (Fig. 7.3). The selected log will be

displayed (Fig.7.5) If a printer is connected to the autoclave, rotate to and press 【Print】to print it out.

Figure 7.5 Log display

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7.4 Read a log file A typical sterilization log file is shown and explained below:

- - - - - - - - - - - - - - - - Quantus Sterilizer - - - - - - - - - - - - - - - - Program : Quick-program-S 134°C unwrapped Data : 2017.07.12 Start Time : 09:11:29 Cycle : 1 SN : 65252120517050513 Preheat Temper : 95.0°C Conductivity :11.0us/cm - - - - - - - - - - - - - - - - Program step press temper time bar °C min Start : -0.04 69.6 0:00:00 1.Vacuum one Sub press : -0.87 72.0 0:02:26 Steam press: 0.50 109.9 0:05:32 2.Vacuum two Sub press : -0.52 89.2 0:06:32 Steam press: 2.14 134.3 0:11:51 - - - - - - - - - - - - - - - - Keep : 2.14 134.3 0:11:51 Keep End : 2.17 135.0 0:16:51 Realse : 0.10 105.6 0:18:27 Dry : 0.10 105.6 0:18:27 Dry End : -0.91 90.3 0:22:27 Ventile : -0.14 92.3 0:22:39 Finish : -0.14 92.3 0:22:39 - - - - - - - - - - - - - - - - PROGRAM PROPERLY EXECUTED! Temperature: 134.7+0.2/-0.4°C Pressure : 2.14+0.02/-0.03bar Sterilization : 0:22:39 End Time : 09:34:08 Hardware Version: Qx3_V0.2 Software Version: 00.02.16.19 - - - - - - - - - - - - - - - -

Model Name Program Date Start time Cycle number Serial number Pre-heat temperature Feed water conductivity

Temperature, pressure during 2-time pre-vacuum

Sterilization start Sterilization end Pressure release Drying start Drying end Ventilation Program finish

Final report including sterilization temperature; pressure; program run time; finish time; Hardware version; Software version.

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8 Maintenance 8.1 Cleaning and preparation of the sterilization load

Items to be sterilized such as hand-piece must be cleaned

thoroughly before sterilization;

Dust and other contaminants separated from the sterilization loads

will clog the filters, valves and pipes in the autoclave. Hence, load

not cleaned properly are not allowed to be sterilized in the

chamber;

It is recommended to clean the sterilization loads such as scissor

with cleaning solutions or by ultrasonic cleaning machine

according to manufacturer’s instructions.

Follow their manufacturers’ instructions for reprocessing of the

medical instruments and textiles.

8.2 Maintenance of the device 8.2.1 Cleaning

Regular cleaning and care are essential for prolong the lifespan of the device and ensuring quality of

sterilization.

Table 8-1 Cleaning and maintenance intervals Maintenance Maintenance period Tool Operation

Replace the seal ring 1000 sterilization cycles Open the door, check whether the seal is deformed or wrinkled, and replace it if so.

Sealing ring Maintenance Two weeks

Take off the sealing ring, use wet clean cloth to clean the sealing ring inside out. Then use dry clean cloth to dry the sealing ring. Put the sealing ring back to the autoclave. Note: the narrower side of the sealing ring should be close to the lid and the wider side of the sealing ring towards to chamber

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Lock Maintenance 100 sterilization cycles Lubricating oil

Spray some oil into the “A” spot at the left side of the lid, clean the outside with a rag.

Clean the distilled water tank 300 sterilization cycles Wash it with clean water

Clean the filter attached to the distilled water pipe 300 sterilization cycles Wash it with clean water

Clean the filters at both ends of the cooling water pipe

100 sterilization cycles Take off the nuts at both ends of the cooling water pipe, wash it with clean water

Clean the filter at the bottom of the chamber 200 sterilization cycles Flat screw

driver Remove the filter with a wrench, and wash it with clean water.

Clean the trays 100 sterilization cycles Wash it with clean water, use toothpaste to clean the stains.

Door Shaft Two weeks Lubricating Oil Spray few drops of lubricating oil

Sterilization Chamber One week Clean and try the chamber with medical cotton cloth

8.2.2 Maintenance

Failure to follow these guidelines may lead to damage of the

autoclave and to injury of health!

Comply with the predetermined maintenance intervals in Table 8-1;

Have maintenance carried out only by manufacturer maintenance

staff. Caution for hot steam and heated metal surface during maintenance.

Wear heat resistance gloves when necessary. Operate the maintenance only when the device is powered off. After maintenance, please be sure the protective earthing conductors

are connected well and the outer case is screwed tightly. Power on the device and run vacuum test to verify.

A

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9 Warnings and errors 9.1 Warnings and errors

The autoclave prompts warning messages whenever necessary to give notice and alert of an erroneous situation.

When warning messages prompt, the autoclave also gives alarm sound. All warning messages are listed below:

Table 9-1 Warnings and errors message Code Warning Message Causes Checking or Maintenance Approaches

Please close the door The door is not closed correctly.

Close the door and push the door handle towards the end

Please drain the tank Water level in the waste water tank is too high

1、Drain water from the waste water tank.

Cool the chamber Temperature in chamber is higher than 45°during vacuum test

1、Open the door; start vacuum test after the chamber is cool.

High Pressure Pressure in chamber >1.04Bar

1、Wait until pressure in chamber becomes atmosphere pressure 2、Contact your distributor if pressure doesn’t become normal

Low Pressure Pressure in chamber <-0.95Bar

1、Wait until pressure in chamber becomes atmosphere pressure 2、Contact your distributor if pressure doesn’t become normal

NO USB Disk USB connection error 1、Check if USB cable is connected 2、Contact your distributor if the warning prompts repeatedly

NO Record

No log is found. It means the autoclave has not run any program or just gone through system reset.

1、Run one sterilization cycle

02 Forced Stop Stop button was pushed when during sterilization cycle

1、Re-run the sterilization cycle after checking the device

03 Door Sensor 1 Door sensor status is open during sterilization cycle

1、Check the door sensors and make sure door is closed tightly and door handle pushed to the end.

2、If same warning prompts repeatedly, contact your distributor.

04 Door Sensor 2 Door sensor status is open during sterilization cycle

1、Check the door sensors and make sure door is closed tightly and door handle pushed to the end.

2、If same warning prompts repeatedly, contact your distributor.

05 Door Sensor 1&2 Door sensor status is open during sterilization cycle

1、Check the door sensors and make sure door is closed tightly and door handle pushed to the end.

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2、If same warning prompts repeatedly, contact your distributor.

06 Preheat Timeout Heater fault 1、Check the heater wrapped around the chamber

2、If same warning prompts repeatedly, contact your distributor.

08 No Dist Water Distilled water pipe is stuck/flow meter signal timeout

1、Check if distilled water pipe is twisted or knotted;

2、Check flow meter

3、If same warning prompts repeatedly, contact your distributor.

09 Water Quality Unqualified distilled water

1、Use better quality distilled water

2、Clean water tank regularly

10 No Cooling Water

1、 Cooling water pipe is not connected properly

2、 Cooling water tap is not switched on

3、 Cooling water pressure does not meet device requirement

1、 Check if cooling water pipe is properly connected

2、 Check if cooling water tap is switched on

3、 Use cooling water supply that meets the device requirement or install additional water pump

11 Vacuum Timeout Vacuum test failure

1. Check and clean seals; 2. Run vacuum test with cool and dried chamber 3. If the message appears repeatedly, please contact your distributor.

Please do not adjust the gate spacing without guide from qualified personnel.

When vacuum test fail, do not perform any operation using the autoclave, please contact your distributor.

13 Steam Timeout Steam Generator Fault 1、Check the steam generator

2、If same warning prompts repeatedly, contact your distributor.

16 Temper SW Open Temperature switch open

1、Check temperature switch and other cable connection

2、If same warning prompts repeatedly, contact your distributor.

17 Release Timeout Exhaust valve fault 1、Check the exhaust valve

Warning

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2、If same warning prompts repeatedly, contact your distributor.

20 System Error System configuration error

1、Check system configuration

2、If same warning prompts repeatedly, contact your distributor.

22 Drain Timeout Draining valve fault 1、Check draining valve

2、If same warning prompts repeatedly, contact your distributor.

23 Levelling Timeout Air filter valve fault 1、Check air filter valve

2、If same warning prompts repeatedly, contact your distributor.

24 Press Max Limit Pressure in chamber exceeds upper limit during operation

1、Stop the device, check the device thoroughly,if no other error,try again

2、If same warning prompts repeatedly, contact your distributor.

26 Press Min Limit Pressure in chamber exceeds lower limit during operation

1、Stop the device, check the device thoroughly,if no other error,try again

2、If same warning prompts repeatedly, contact your distributor.

25 Temper Max Limit Temperature in chamber exceeds upper limit during operation

1、Stop the device, check the device thoroughly,if no other error,try again

2、If same warning prompts repeatedly, contact your distributor.

27 Temper Min Limit Temperature in chamber exceeds lower limit during operation

1、Stop the device, check the device thoroughly,if no other error,try again

2、If same warning prompts repeatedly, contact your distributor.

30 Balance Timeout Leaking 1、Check pipelines, door sealing, chamber opening for leakage

9.2 Common issues and troubleshooting

If the solutions below do not work, please contact HäTmed distributor.

9.2.1 Screen No Display

Situation: No display or abnormal display after power on the autoclave.

Solution:

Check whether the power outlet has power;

Check whether the power plug of the autoclave is inserted.

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9.2.2 Large Consumption of Distilled Water

Situation: The consumption of distilled water is larger than normal.

Solution:

Check the foot pads, the front ones should be higher than the rear ones;

Check whether the filter at the bottom of the chamber is stuck.

9.2.3 Load not dried sufficiently

Situation: Loads are not dried sufficiently.

Solution:

Check the foot pads, the front ones should be higher than the rear ones;

Check whether the filter net at the bottom of the chamber is stuck;

Check whether the maximum load capacity is exceeded (especially textile), whether the sterilization

load is placed correctly and allows easy dissipation of steam.

Activate the preheating function;

Open the left side panel, check if the filter is stuck.

9.2.4 No Distilled Water

Situation: No Distilled Water.

Solution:

Check if the distilled water tank has sufficient water in it;

Check if the distilled water pipe is twisted or knotted.

9.2.5 Leaking air or water at the door opening

Situation: Observable air leaking or water drops at the door opening.

Solution:

Check if the sealing ring is placed corrected (Wider side with “H” mark towards the chamber);

Check if the sealing ring is broken.

9.2.6 Cannot open the door

Situation: Cannot open the door even with emergency door open tool

Solution:

Check air filter opening at the rear is covered or blocked;

Open the outer case of the device, plug off the silicon tube connected on the air filter valve;

Pressure will be released from the chamber and you can hear sound of leaking air;

When the sound is diminishing, you can try to open the door;

Connect the pipe to its original location and clip the clamping ring tight;

Switch on the device and run vacuum test to check leakage.

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Appendix 1 Safety mechanism To ensure that the device is safe and reliable, a series of protective mechanism are implemented.

Preheating system over-temperature protection switch: There is an over-temperature protection switch in the

preheating system. When the temperature exceeds the threshold of the over-temperature protection switch, the

power supply circuit of the preheating system will be automatically cut off to protect the preheating system.

Steam generator over-temperature protection switch: There is an over-temperature protection switch under

the steam generator. When the temperature of the steam generator exceeds the threshold of the over-temperature

protection switch, the power supply circuit of the steam generator will be automatically cut off to protect the

steam generator.

The safety valve for the chamber: When the pressure in the chamber reaches the safety threshold, the safety

valve opens automatically to keep pressure in the chamber in safe range.

The safety valve for the steam generator: When the pressure in the steam generator reaches the safety

threshold, the safety valve opens automatically to keep pressure in the steam generator in safe range.

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Appendix 2 Block diagram

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Appendix 3 Electrical diagram